Nebulizer

ABSTRACT

A nebulizer for a fluid having a pressure generator for conveying and nebulizing the fluid, particularly in the form of an inhaler, is proposed. To improve the user guidance it is envisaged that the nebulizer should have a signal device for generating at least one acoustic and/or vibratory signal, particularly during a nebulizing process.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a nebulizer according to the preambleof claim 1.

2. Description of the Prior Art

The starting point for the present invention is a nebulizer in the formof an inhaler as shown in principle in WO 91/14468 and specifically inWO 97/12687 (FIGS. 6a, 6b) and in FIGS. 1 and 2 of the encloseddrawings. The nebulizer comprises as a reservoir for a fluid which is tobe nebulised an insertable container with the fluid and a pressuregenerator with a drive spring for conveying and atomising the fluid. WO91/14468 and WO 97/12687 are hereby incorporated by reference in theirentireties. Generally, the disclosures thereof refer to a nebulizerhaving a spring pressure of 5 to 60 MPa, preferably 10 to 50 Mpa, on thefluid with volumes per actuation of 10 to 50 μl, preferably 10 to 20 μl,most preferably about 15 μl, per actuation and particle sizes of up to20 μm, preferably 3 to 10 μm. Moreover, the disclosures thereinpreferably relate to a nebulizer with a cylinder-like shape that isabout 9 cm to about 15 cm long and about 2 to about 5 cm wide and anozzle spray spread of from 20° to 160°, preferably from 80° to 100°.These magnitudes also apply to the nebulizer according to the teachingof the invention as particularly preferred values.

By rotating an actuating member in the form of a lower housing part ofthe nebulizer the drive spring can be put under tension and fluid can bedrawn up into a pressure chamber of the pressure generator. After manualactuation of a locking element the fluid in the pressure chamber is putunder pressure by the drive spring and nebulized, i.e. expelled to forman aerosol. During the tensioning process, on the one hand, andsubsequent atomizing, on the other hand, the container performs alifting movement.

The nebulizer comprises a mechanical monitoring device which detects therotation of the actuating member in order to count the actuations of thenebulizer. The known nebulizer operates exclusively mechanically, i.e.without propellant gas and without electricity.

SUMMARY OF THE INVENTION

The aim of the present invention is to provide a nebulizer which hasbetter guidance for the user.

This objective is achieved by a nebulizer according to claim 1.Advantageous features are recited in the subsidiary claims.

A fundamental idea of the present invention consists in providing asignal device for generating at least one acoustic and/or vibratorysignal for user guidance. This provides better information for the user,even during the inhaling process, in particular, so as to allow betterhandling and safety in use.

In the present invention the term “vibratory signal” is preferably to beunderstood in a wider sense as meaning that it includes other tactilesignals such as the movement of part of the nebulizer, movement orrelease of an actuating element or the like.

In particular, the nebulizer comprises a mouthpiece, so that the userputs the mouthpiece in their mouth in order to use the nebulizer. Duringthe nebulizing and inhaling process, any optical display which may beshowing on the nebulizer cannot be seen by the user. However, anacoustic and/or vibratory signal can be registered by the user evenduring the inhalation process.

A particular advantage of a vibratory signal is that when a user isholding a mouthpiece any vibratory signal can be relatively weak, i.e.may have a low amplitude, but will still be very easily perceived by theuser.

Alternatively or in addition to the detection of the vibratory signalthrough a mouthpiece, the nebulizer may also be designed so that thevibratory signal can be perceived by the hand of the user holding thenebulizer, particularly a finger. It may be sufficient if for exampleonly a section or part of the nebulizer, such as an operating button,vibrates or generates some other tactile signal such as a movement.

Another advantage resides in the discreet nature of the arrangement, asthe user can detect a vibratory signal without the signal beingnoticeable to third parties.

According to an alternative embodiment a signal can be producedthroughout the nebulizing process and/or at the end of the nebulizingprocess, to inform the user accordingly.

Alternatively or in addition, starting with a nebulizing process, asignal can be generated throughout a predetermined period of time and/orafter this period has elapsed. This signal indicates to a user the idealor necessary inhalation period, or the time for which a user should holdtheir breath immediately after inhaling, or the end of this time once ithas been correspondingly selected—e.g. 1 to 15 seconds longer than thenebulizing process.

Alternatively or in addition, a signal may be generated throughout anactual inhalation process and/or at the end of an actual inhalationprocess, while the signal may also depend on the intensity of inhalationand may possibly indicate that inhalation has been sufficiently powerfulor not powerful enough. In particular, the nebulizer comprises a sensorin the region of a mouthpiece of the nebulizer, for detecting an airsupply current sucked in by the user as they inhale and therebydetecting the inhalation.

Preferably the nebulizer indicates to the user, by means of the signalor different signals, the start, duration and/or end of the nebulizingprocess, a subsequent (ideal or actual) period of inhalation and/or adesired period of time, preferably from about 5 to 15 seconds, duringwhich a user should hold their breath immediately after inhaling.

According to a particularly preferred alternative feature the signaldevice like the pressure generator operates exclusively mechanically,i.e. without electricity, propellant gas or the like.

DESCRIPTION OF THE DRAWINGS

Further advantages, features, properties and aspects of the presentinvention will become apparent from the following description ofpreferred embodiments referring to the drawings, wherein:

FIG. 1 is a diagrammatic section through a known nebulizer in theuntensioned state;

FIG. 2 shows a diagrammatic section through the known atomiser in thetensioned state, rotated through 90° compared with FIG. 1;

FIG. 3 is a diagrammatic sectional view of a detail of a proposednebulizer according to a first embodiment with a signal device in thetensioned state;

FIG. 4 is an enlarged view of a detail from FIG. 3 with the signaldevice untensioned;

FIG. 5 is a diagrammatic sectional view of a detail of a proposednebulizer according to a second embodiment with a signal device in thetensioned state; and

FIG. 6 is an enlarged view of a detail from FIG. 5.

In the Figures, identical reference numerals are used for identical orsimilar parts, and corresponding or comparable properties and advantagesare achieved even if the description is not repeated.

DESCRIPTION OF THE INVENTION

FIGS. 1 and 2 show a known nebulizer 1 for nebulizing a fluid 2,particularly a highly effective pharmaceutical composition or the like,viewed diagrammatically in the untensioned state (FIG. 1) and in thetensioned state (FIG. 2). The nebulizer is constructed in particular asa portable inhaler and preferably operates without propellant gas.

When the fluid 2, preferably a liquid, more particularly apharmaceutical composition, is nebulised, an aerosol is formed which canbe breathed in or inhaled by a user. Usually the inhaling is done atleast once a day, more particularly several times a day, preferably atset intervals.

The nebulizer 1 has an insertable and preferably exchangeable container3 containing the fluid 2, which forms a reservoir for the fluid 2 whichis to be nebulised. Preferably, the container 3 contains an amount offluid 2 sufficient for multiple use, particularly for a given period ofadministration, such as one month, or for at least 50, preferably atleast 100, doses or sprays.

The container 3 is substantially cylindrical or cartridge-shaped andonce the nebulizer 1 has been opened the container can be insertedtherein from below and changed if desired. It is preferably of rigidconstruction, the fluid 2 in particular being held in a bag 4 in thecontainer 3.

The nebulizer 1 has a pressure generator 5 for conveying and nebulizingthe fluid 2, particularly in a preset and optionally adjustable dosageamount. The pressure generator 5 has a holder 6 for the container 3, anassociated drive spring 7, only partly shown, with a locking element 8which can be manually operated to release it, a conveying tube 9 with anon-return valve 10, a pressure chamber 11 and an expulsion nozzle 12 inthe region of a mouthpiece 13.

As the drive spring 7 is axially tensioned the holder 6 with thecontainer 3 and the conveying tube 9 is moved downwards in the drawingsand fluid 2 is sucked out of the container 3 into the pressure chamber11 of the pressure generator 5 through the non-return valve 10. As theexpulsion nozzle 12 has a very small cross section of flow and isconstructed in particular as a capillary, such a strong throttle actionis produced that the intake of air by suction is reliably prevented atthis point even without a non-return valve.

During the subsequent relaxation after actuation of the locking element8 the fluid 2 in the pressure chamber 11 is put under pressure by thedrive spring 7 moving the conveying tube 9 back upwards—i.e. by springforce—and is expelled through the expulsion nozzle 12 where it isnebulised, particularly into particles in the micron or nm range,preferably particles destined for the lungs measuring about 5 microns,which form a cloud or jet of aerosol 14, as indicated in FIG. 1. Theconveying and nebulizing of the fluid 2 are thus carried out purelymechanically, in particular without propellant gas and withoutelectricity.

A user can inhale the aerosol 14, while an air supply can be sucked intothe mouthpiece 13 through at least one air supply opening 15.

The nebulizer 1 comprises an upper housing part 16 and an inner part 17which is rotatable relative thereto, on which an in particular manuallyoperable housing part 18 is releasably fixed, particularly fitted on,preferably by means of a retaining element 19. In order to insert and/orreplace the container 3 the housing part 18 can be detached from thenebulizer 1.

By manually rotating the housing part 18 the inner part 17 can berotated relative to the upper housing part 16, by means of which thedrive spring 7 can be tensioned in the axial direction by means of agear acting on the holder 6. During tensioning the container 3 is movedaxially downwards until the container 3 assumes an end position as shownin FIG. 2 in the tensioned state. During the nebulizing process thecontainer 3 is moved back into its original position by the drive spring7. The container thus performs a stroke during the tensioning processand during the nebulizing process.

The housing part 18 preferably forms a cap-like lower housing part andfits around or over a lower free end portion of the container 3. As thedrive spring 7 is tensioned the container 3 moves with its end portion(further) into the housing part 18 or towards the end face thereof,while an axially acting spring 20 arranged in the housing part 18 comesto bear on the base 21 of the container and pierces the container 3 or abase seal thereon with a piercing element 22 when the container makescontact with it for the first time, to allow air in.

The nebulizer 1 comprises a monitoring device 23 which counts theactuations of the nebulizer 1, preferably by detecting the rotation ofthe inner part 17 relative to the upper part 16 of the housing. Themonitoring device 23 operates purely mechanically in the embodimentshown.

The construction and mode of operation of a proposed nebulizer 1 willnow be described in more detail, referring to FIGS. 3 to 6, butemphasizing only the essential differences from the nebulizer 1according to FIGS. 1 and 2. The remarks relating to FIGS. 1 and 2 thusapply accordingly.

FIG. 3 shows, in a highly diagrammatic sectional view of only certaindetails, a proposed nebulizer 1 according to a first embodiment with asignal device 24 for generating at least one acoustic and/or vibratoryor otherwise tactile signal for guiding the user when using thenebulizer 1.

The signal device 24 preferably operates exclusively mechanical.Alternatively, however, the signal device 24 may also operateelectrically or pneumatically, for example.

If necessary, the signal device 24 can be driven by the pressuregenerator 5, particularly the drive spring 7 thereof. However, thesignal device 24 preferably comprises an energy store or driveparticularly a spring store 25, independent of the pressure generator 5.In the embodiment shown, the spring store 25 is formed by a helicalspring.

The signal device 24, particularly the spring store 25 thereof, canpreferably be tensioned together with the pressure generator 5,particularly by a part such as the holder 6 of the pressure generator 5,particularly by rotating the housing part 18 and hence the inner part17.

In the first embodiment the signal device 24 is preferably arranged inor on the inner part 17 which is rotatable, particularly for tensioningthe nebulizer 1. However, the signal device 24 may also be mounted on orin some other suitable part of the nebulizer 1.

The signal device 24 comprises a preferably plate shaped impact element26 and a tappet 27 or the like for actuating the impact element 26.Instead of the impact element 26 it is also possible to use any othersuitable component for producing an acoustic and/or vibratory signal onstriking the tappet 27.

The spring store 25 prestresses the tappet 27 towards the impact element26. FIG. 3 shows the signal device 24 in the tensioned state; the tappet27 is thus at a spacing from the impact element 26.

The tensioning of the tappet 27 counter to the force of the spring store25 is preferably carried out in the embodiment shown together with thetensioning of the pressure generator 5. In particular, a tensioning cam28 which is mounted on an axially moveable part of the pressuregenerator 5, particularly the holder 6 or a part connected therewith,engages on the tappet 27 as indicated in FIG. 3. The pressure generator5 and the signal device 24 are thus preferably tensioned in the samedirection.

In the tensioned state the tappet 27 can be located by means of alocking member 29 preferably in the form of a pin. The locking member 29is preferably spring loaded and when the tensioned position is reachedit automatically assumes its locking position as shown in FIG. 3.

The signal device 24 may be initiated or switched on by the pressuregenerator 5, particularly at the beginning and/or end of a nebulizingprocess.

In the embodiment shown the signal device 24 can only be initiated orswitched on at the end of a nebulizing process. In particular, this isdone by the pressure generator 5 shortly before or on reaching itsuntensioned state. In particular, a releasing cam 30 unlocks the signaldevice 24, as the releasing cam 30 meets the locking member 29 andpresses it into a released position, so that the tappet 27 is moved andmore particularly accelerated towards the impact element 26 by the forceof the spring store 25 and strikes the impact element 26, producing thedesired signal. The diagrammatic sectional view of a detail of thenebulizer 1 shown in FIG. 4 shows the signal device 24 in its relaxedstate, i.e. during or after production of the signal.

Preferably, the tensioning cam 28 and the releasing cam 30 are arrangedor formed on a common cam slide 31, as shown in FIG. 3.

Preferably, the cam slide 31 is moveable in order to tension thepressure generator 5 and during the nebulizing process.

In the first embodiment the signal device 24 generates a signal at theend of the nebulizing process in order to indicate to the user that thenebulizing process has ended. In particular, the signal device 24 isinitiated or switched on by the pressure generator 5 at the end of anebulizing process.

Alternatively or in addition, the signal device 24 may be initiated orswitched on by the pressure generator 5 at the start of a nebulizingprocess. This is particularly advantageous when a signal is producedthroughout the entire nebulizing process which indicates to the userthat the nebulizing process is occurring. For example, this can be doneby having the signal device 24 produce an airflow, e.g. by means of thetappet 27 or a piston, and this airflow in turn generates the desiredsignal, e.g. by means of a whistle or the like.

The signal device 24 can thus generate a signal additionally oralternatively throughout the duration of a nebulizing process.

According to an alternative embodiment, different signals can preferablybe produced, e.g. to indicate the (ongoing) nebulizing process and toindicate the end of the nebulizing process.

If the signal device 24 can produce different signals, these preferablydiffer in their sound, duration, loudness, pitch or the like. Accordingto an alternative embodiment, the signal device 24 is constructed sothat acoustic or vibratory signals can be produced as required. Thiscontributes to making the nebulizer 1 universally useable. If the signaldevice 24 can generate vibratory signals the nebulise 1 can be used oruser more easily by those with hearing loss, in particular. Preferably,the signal generation can be switched off if desired and/or the user canchoose whether to receive an acoustic signal, a vibratory signal or bothtypes of signal from the signal device 24.

The nebulizing process usually lasts about 1 to 2 seconds. However, theinhalation process should be continued for about another 1 to 2 secondsin order that as much as possible of the nebulised fluid 2 or the cloudof aerosol 14 produced can be inhaled. Moreover, the user should holdthe air in for about 5 to 15 seconds after breathing in or inhaling. Forthis reason, according to a particularly preferred embodiment, it isprovided that the signal is only emitted after a certain delay after theend of the nebulizing process and/or a certain time after the end of thenebulizing. Preferably, therefore, the signal can be emitted during apredetermined time and/or after the predetermined time, particularlybeginning with a nebulizing process, the time preferably being measuredso that the user is informed of the recommended or required inhalationperiod of for example about 3 to 4 seconds or the recommended period ofabout 5 to 15 seconds of holding their breathe.

The above mentioned signal production may be carried out for example byinitiating the signal device 24 only at the end of a nebulizingprocess—e.g. by the pressure generator 5—after which a signal isproduced for a period of e.g. 1 to 15 seconds or only after 1 to 15seconds. This can be achieved for example by producing an air current bymeans of the tappet 27 for directly generating a signal or for slowingdown or attenuating the movement of the tappet towards the impactelement 26.

Instead of a mechanical delay or a mechanical timer, if necessary anelectronic timer can be used to produce the above mentioned delay orlength of time to indicate the recommended or required inhalationprocess or the end thereof. In this case the signal device preferablyworks electrically or electronically.

According to another alternative embodiment the signal device 24 mayalso be adapted to be initiated independently of the pressure generator5 or, for example, simultaneously by actuation of the locking element 8.

In a diagrammatic sectional view FIG. 5 shows a second embodiment of theproposed nebulizer with a different signal device 24. FIG. 6 shows anenlarged view of a detail from FIG. 5.

The signal device 24 comprises at least one ratchet element 32, in theembodiment shown two ratchet elements 32, which is or are moveableduring a nebulizing process by means of a latch 33 to generate anacoustic signal. In particular, the relative movement of the latchingmeans 33 to the ratchet elements 32 is carried out by the pressuregenerator 5 or its drive spring 7 during the nebulizing process.

Preferably, the latching means 33 are formed on the holder 6 or on acomponent connected thereto.

The ratchet elements 32 are preferably shaped like fingers and areparticularly mounted or formed, preferably integrally formed, on theinner part 17 of the nebulizer 1.

The ratchet elements 32 are preferably elastically and particularlyinherently elastically biased against the latching means 33.

In the second embodiment, the signal device 24 can emit an acousticand/or vibratory signal during a nebulizing process as a result of theratchet elements 32 moving over the latching means 33.

The latching means 33 may be formed by a thread so that when thelatching means 33 are rotated relative to the ratchet elements 32 duringthe tensioning process the production of a signal can be avoided.Alternatively, the emitting of a signal during the tensioning processcan also be prevented by other means or some other constructionalsolution.

The embodiments described above and particularly individual elements andaspects of the embodiments may if required be combined with one anotherand/or kinematically reversed.

1. A nebulizer, comprising a pressure generator means for conveying andnebulizing a fluid and a signal device having means for generating atleast one acoustic or vibratory signal for user guidance as toperformance of an individual nebulizing process; wherein the signaldevice comprises different parts of the nebulizer from those which formthe pressure generator means and wherein said means for generating atleast one acoustic or vibratory signal comprises at least one elementwhich produces said at least one acoustic or vibratory signal, inaddition to any sound or vibration produced by the pressure generatormeans, by movement in a lengthwise direction of the nebulizer.
 2. Thenebulizer according to claim 1, further comprising a pressure generatoradapted for triggering operation of the signal device.
 3. A nebulizerfor nebulizing a fluid, comprising a pressure generator means forconveying and nebulizing a fluid and a signal device having means forgenerating at least one acoustic or vibratory signal for user guidance,wherein the signal device comprises an energy store or drive independentof the pressure generator means, the signal device being formed ofdifferent parts of the nebulizer from those which form the pressuregenerator means, and wherein the signal device produces said acoustic orvibratory signal in addition to any sound or vibration produced by thepressure generator means.
 4. The nebulizer according to claim 1,characterised in that the signal device is a mechanically operatingsignal device.
 5. The nebulizer according to claim 1, characterised inthat the signal device has an energy store comprising a spring store. 6.The nebulizer according to claim 5, characterised in that the springstore can be manually tensioned by a holder of a pressure generator fora container with a fluid to be nebulized.
 7. The nebulizer according toclaim 1, characterised in that the signal device comprises asubstantially flat impact element which can be actuated in order togenerate the signal.
 8. The nebulizer according to claim 5,characterised in that the signal device comprises a tappet that can beactuated in order to generate the signal, and in that the tappet can bemoved towards an impact element by the spring store in order to generatethe signal.
 9. The nebulizer according to claim 8, further comprising atensioning cam which tensions the tappet counter to the force of thespring store.
 10. The nebulizer according to one of claims 9, furthercomprising a locking means for locking that the tappet in the tensionedstate.
 11. The nebulizer according to claim 10, further comprising apressure generator adapted for triggering operation of the signaldevice, wherein the tappet can be released by the pressure generator bymeans of a releasing cam.
 12. The nebulizer according to claims 11,characterised in that the tensioning cam and the releasing cam areformed on a common cam slide.
 13. The nebulizer according to claim 12,characterised in that the cam slide is moveable for tensioning thepressure generator and during the nebulizing process.
 14. The nebulizeraccording to claim 3, wherein the signal device is a mechanicallyoperating signal device.
 15. The nebulizer according to claim 3, whereinthe signal device has an energy store comprising a spring store.
 16. Thenebulizer according to claim 15, further comprising a holder of apressure generator for a container with a fluid to be nebulized, whereinthe spring store can be manually tensioned by the holder.
 17. Thenebulizer according to claim 15, wherein the signal device comprises asubstantially flat impact element which is actuatable for generating thesignal.
 18. The nebulizer according to claim 15, wherein the signaldevice comprises a tappet that can be actuated for generating thesignal, and wherein the tappet is movable towards an impact element bythe spring store to generate the signal.
 19. The nebulizer according toclaim 18, further comprising a tensioning cam which tensions the tappetcounter to the force of the spring store.
 20. The nebulizer according toclaim 19, further comprising a locking means for locking that the tappetin the tensioned state.
 21. The nebulizer according to claim 20, whereinthe pressure generator is adapted for triggering operation of the signaldevice, wherein the tappet can be released by the pressure generator bymeans of a releasing cam.
 22. The nebulizer according to claim 21,wherein the tensioning cam and the releasing cam are formed on a commoncam slide.
 23. The nebulizer according to claim 22, wherein the camslide is moveable for tensioning the pressure generator and during thenebulizing process.
 24. The nebulizer according to claim 3, wherein thepressure generator is adapted for triggering operation of the signaldevice.
 25. The nebulizer according to claim 3, wherein the signaldevice is a mechanically operating signal device.
 26. The nebulizeraccording to claim 3, wherein the signal device has an energy storecomprising a spring store.
 27. The nebulizer according to claim 26,further comprising a holder of a pressure generator for a container witha fluid to be nebulized, wherein the spring store can be manuallytensioned by the holder.
 28. The nebulizer according to claim 3, whereinthe signal device comprises a substantially flat impact element which isactuatable for generating the signal.
 29. The nebulizer according toclaim 26, wherein the signal device comprises a tappet that can beactuated for generating the signal, and wherein the tappet is movabletowards an impact element by the spring store to generate the signal.30. The nebulizer according to claim 29, further comprising a tensioningcam which tensions the tappet counter to the force of the spring store.31. The nebulizer according to claim 30, further comprising a lockingmeans for locking that the tappet in the tensioned state.
 32. Thenebulizer according to claim 31, wherein the pressure generator isadapted for triggering operation of the signal device, wherein thetappet can be released by the pressure generator by means of a releasingcam.
 33. The nebulizer according to claim 32, wherein the tensioning camand the releasing cam are formed on a common cam slide.
 34. Thenebulizer according to claim 33, wherein the cam slide is moveable fortensioning the pressure generator and during the nebulizing process. 35.The nebulizer according to claim 1, wherein the signal device comprisesan energy store or drive.